A Comparison of Olopatadine and Fluticasone in Patients With Allergic Conjunctivitis

Sponsor

Greiner, Jack V., OD DO PhD (Other)

Overall Status

Completed

CT.gov ID

NCT00655109

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis, Allergic	Drug: Olopatadine Drug: Fluticasone Drug: Saline Drug: Artificial tears	Phase 4

Detailed Description

Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Olopatadine	Drug: Olopatadine Ophthalmic solution
Active Comparator: 2 Fluticasone	Drug: Fluticasone Nasal spray
Placebo Comparator: 3 Placebo nasal spray	Drug: Saline Nasal spray
Placebo Comparator: 4 Placebo Eyedrops	Drug: Artificial tears Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

Ocular itching [Minutes following CAC]

Secondary Outcome Measures

Ocular redness [Minutes following CAC]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

At least 18 years of age & either sex, any race
Willing and able to follow all instructions and attend all study visits
Positive history of ocular allergies
Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge